Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

Administrative data

Endpoint:
in vivo insect germ cell study: gene mutation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
publication
Title:
Genetic toxicity study of the test chemical
Author:
King et al
Year:
1979
Bibliographic source:
Mutation Research

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPPTS 870.5275 (Sex-linked Recessive Lethal Test in Drosophila melanogaster)
GLP compliance:
not specified
Type of assay:
Drosophila SLRL assay

Test material

Constituent 1
Reference substance name:
2-acetyloxybenzoic acid
Cas Number:
50-78-2
Molecular formula:
C9H8O4
IUPAC Name:
2-acetyloxybenzoic acid
Test material form:
solid: crystalline
Details on test material:
- Name of test material: Acetylsalicylic acid
- Molecular formula: C9H8O4
- Molecular weight: 180.16 g/mol
- Substance type: Organic
- Physical state: Solid
- Impurities (identity and concentrations): The chemical was of the finest or spectroscopically pure grade

Test animals

Species:
Drosophila melanogaster
Strain:
other: Berlin K
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
The test chemical was dissolved in 5% sucrose solution containing 2% DMSO if necessary
Details on exposure:
The test chemical was given by diet to 1-2 day old Berlin K males for 3 consecutive days, normally at the single maximally tolerated dose level (up to the LD50).
Duration of treatment / exposure:
3 days
Frequency of treatment:
daily by diet
Post exposure period:
After treatment, a sequence of three brood periods (each lasting 3 days) was then initiated. At the end of each 3-day breeding period, treated males were transferred to new vials and mated individually with 3 virgin females. Typically, at least 1000 F1 females were handled in each brood.
Doses / concentrations
Remarks:
0 (vehicle and 10 mM
No. of animals per sex per dose:
Number of males not specified but at least 1000 F1 females were handled in each brood.
Control animals:
yes, plain diet
Positive control(s):
1,2 dichloroethane, which is a probable carcinogen in humans, was evaluated in addition to the test chemical for mutagenic effects in Drosophila.

Examinations

Tissues and cell types examined:
X-chromosomes
Details of tissue and slide preparation:
No details given.
Evaluation criteria:
Recessive lethal mutations frequencies in brood I, II, III, and I to III, in F2 and F3 generations, following treatment with the test chemical in males, were evaluated against solven control data using statistical analysis.
Statistics:
Kastenbaum-Bowman test

Results and discussion

Test results
Key result
Sex:
male/female
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid

Any other information on results incl. tables

Table 1. Data for solvent control and for the positive control (1,2-dichloroethane at 50 mM).

Conc.

Brood

Days after treatment

Number of X-chromosomes tested

Number of lethals

Recessive lethal mutation frequency (%)

P values

0

I

0-3

9565

24

0.25

 NS

0

II

4-6

6500

4

0.06

 NS

0

III

7-9

5983

19

0.32

 NS

0

I-III

0-9

22048

47

0.21

 NS

50

I

0-3

1185

6

0.51

 NS

50

II

4-6

1179

41

3.48

<0.01

50

III

7-9

156

2

1.28

 NS

50

I-III

0-9

2520

49

1.94

<0.01

NS = not statistically significant.

Note 1: The relatively low mutation frequency in brood II at 0 mM (of 0.06%) was consistent with historical control data.

Note 2: No tabular data was presented for the test chemical at 10 mM but it was concluded by the authors to be non-mutagenic in the text.

Applicant's summary and conclusion

Conclusions:
Three days treatment with the test chemical Drosophila at LD50 resulted in no significant increase in the frequency of sex-linked recessive lethal mutations in any of the broods or in all broods combined when compared to concurrent negative control data.
Executive summary:

The chemical was given via diet at 0 and 10 mM for 3 days to 1-2 day old Berlin K males. A single dose of 10 mM corresponded to the LD50 value and was regarded to be the maximally tolerated dose in the insects. Treated males were mated individually with 3 Basc virgin females. A sequence of three brood periods (each lasting 3 days) was then initiated. At the end of each 3-day breeding period, treated males were transferred to new vials and mated individually with 3 virgin females. Typically, at least 1000 F1 females were handled in each brood. Sex-linked recessive lethal mutations were scored in the F2 and F3 generations. Treatment with the test chemical resulted in no significant increase in the frequency of sex-linked recessive lethal mutation in any of the broods or in all broods combined when compared to concurrent negative control data. Treatment with 1,2 dichloroethane, which is a probable human carcinogen, at 50 mM resulted in a significant increase in the frequency of sex-linked recessive lethal mutations in brood 2 and in all broods combined when compared to control data, indicating that the assay was valid for detecting mutagenic effects.